Government-Owned Inventions; Availability for Licensing, 16602-16603 [2021-06476]

Download as PDF 16602 Federal Register / Vol. 86, No. 59 / Tuesday, March 30, 2021 / Notices confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; New Investigator Gateway Awards for Collaborative T1D Research Special Emphasis Panel. Date: April 6, 2021. Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Video Meeting). Contact Person: Peter J. Kozel, Ph.D., Scientific Review Officer, Review Branch, Division of Extramural Activities, NIDDK, National Institutes of Health, Room 7009, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–4721, kozelp@ mail.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–06470 Filed 3–29–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Chimeric Antigen Receptors Targeting CD56 AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Memorial Sloan Kettering Cancer Center, (‘‘MSKCC’’), a non-profit research center located in New York, in its rights to the inventions and patents listed in the SUPPLEMENTARY INFORMATION section of this notice. DATES: Only written comments and/or applications for a license which are jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:59 Mar 29, 2021 Jkt 253001 received by the NCI Technology Transfer Center April 14, 2021 will be considered. Requests for copies of the patent applications, inquiries, and comments relating to the contemplated exclusive patent license should be directed to: Rose M. Freel, Ph.D., Senior Licensing and Patenting Manager at Telephone: (301) 624–8775 or Email: rose.freel@nih.gov. ADDRESSES: The following and all continuing U.S. and foreign patents/patent applications thereof are the intellectual properties to be licensed under the prospective agreement to MSKCC: U.S. Provisional Patent Application No. 62/199,775, filed July 31, 2015 entitled ‘‘Antigen-Binding Proteins Targeting CD56 And Uses Thereof,’’ (HHS Ref. No. E–142–2014–0– US–01); PCT Application No. PCT/ US16/045027, filed August 2, 2016 entitled ‘‘Antigen-binding proteins targeting CD56 and uses thereof’’ (HHS Ref. No. E–142–2014–0–PCT–02); U.S. Patent No. 10,730,941, granted on August 4, 20201, corresponding to U.S. Patent Application No. 15/884,608, filed January 31, 2018, entitled ‘‘Antigenbinding proteins targeting CD56 and uses thereof’’ (HHS Ref. No. E–142– 2014–0–US–03); Canadian Patent Application No. 2994412, filed January 31, 2018, entitled ‘‘Antigen-binding proteins targeting CD56 and uses thereof’’ (HHS Ref. No. E–142–2014–0– CA–04); Australian Patent Application No. 16833684.0, filed January 31, 2018, entitled ‘‘Antigen-binding proteins targeting CD56 and uses thereof’’ (HHS Ref. No. E–142–2014–0–AU–05); U.S. Patent Application No. 16/912,291, filed June 25, 2020, entitled ‘‘Methods of treatments using antigen-binding proteins targeting CD56’’ (HHS Ref. No. E–142–2014–0–US–06). The patent rights in these inventions have been assigned to the Government of the United States of America and Memorial Sloan Kettering Cancer Center. The prospective patent license will be for the purpose of consolidating the patent rights to MSKCC, one of the co-owners of said rights, for commercial development and marketing. Consolidation of these co-owned rights is intended to expedite development of the invention, consistent with the goals of the Bayh-Dole Act codified as 35 U.S.C. 200–212. The prospective patent license will be worldwide, exclusive, and may be limited to those fields of use commensurate in scope with the patent rights. It will be sublicensable, and any sublicenses granted by MSKCC will be SUPPLEMENTARY INFORMATION: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 subject to the provisions of 37 CFR part 401 and 404. The invention pertains to novel antibody binders and chimeric antigen receptors (CARs) that target CD56 or NCAM, a glycoprotein that is highly expressed in a variety of cancerous cells. Based on current available data, the intended use for the invention is anti-CD56 CARs for the treatment of CD56 positive cancers such as multiple myeloma. This notice is made pursuant to 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent license will include terms for the sharing of royalty income with NCI from commercial sublicenses of the patent rights and may be granted unless within fifteen (15) days from the date of this published notice the NCI receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. Complete applications for a license that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent license. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C § 552. Dated; March 10, 2021. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2021–06474 Filed 3–29–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is owned by an agency of the U.S. Government and is available for SUMMARY: E:\FR\FM\30MRN1.SGM 30MRN1 Federal Register / Vol. 86, No. 59 / Tuesday, March 30, 2021 / Notices licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Elizabeth Pitts, Ph.D., 240–669–5299; elizabeth.pitts@nih.gov. Licensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to the invention. SUPPLEMENTARY INFORMATION: Technology description follows. jbell on DSKJLSW7X2PROD with NOTICES Protein Nanoparticle-Based Vaccine for Influenza Virus Description of Technology There is a great need for a broadly protective, ‘‘universal’’ influenza virus vaccine. Most influenza vaccines target the head of the influenza surface glycoprotein hemagglutinin (HA). However, this region of the HA protein undergoes fast antigenic drift. The current strategy to address this issue is to reformulate influenza vaccines annually against dominant circulating strains, but this leads to variable protective efficacy against annual epidemic strains and will not provide protection against novel influenza viruses with pandemic potential. A ‘‘universal’’ influenza vaccine could improve seasonal vaccination and provide pandemic preparedness. Broadly neutralizing antibodies with heterosubtypic binding have been discovered. However, commercial development of vaccines that produce broadly neutralizing antibodies has so far been unsuccessful. Researchers at NIAID used structure-guided techniques to identify and develop nanoparticles that express a conserved peptide from the HA stem, a preferred antigen for influenza vaccine development as it evolves slower than the HA head. The nanoparticles of this invention elicit antibodies to the HA stem, confer protection in mouse challenge models, are cross-reactive to heterosubtypic HA subtypes, and are heat stable. Additionally, the protein platform of the nanoparticles can be expressed for group 1 and group 2 influenza HA (H1 to H16), which allows mixing of VerDate Sep<11>2014 17:59 Mar 29, 2021 Jkt 253001 antigens. This vaccine technology has great potential to provide protection against both annual influenza outbreaks and pandemic-potential influenza viruses. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404. Potential Commercial Applications • Vaccines against influenza virus. • Universal influenza virus vaccine. • Broad/universal protection against both seasonal and pandemic-potential influenza viruses. • Nanoparticles allow mixing of antigens. • Incorporates epitopes from group 1 and groups 2 influenza viruses. • Stability of particle and immunogenicity after high temperature exposure. Development Stage • In vivo data assessment (animal). Inventors: Audray K. Harris (NIAID) and Dustin McCraw (NIAID). Intellectual Property: HHS Reference No. E–005–2017—U.S. Provisional Application No. 62/540,474, filed August 2, 2017; PCT Application No. PCT/US2018/045032, filed August 2, 2018; United States Application No. 16/ 635,240, filed January 30, 2020 (pending); European Application No. 18756111.3, filed August 2, 2018 (pending); Chinese Application No. 201880063622.5, filed August 2, 2018 (pending); and Indian Application No. 202017008138, August 2, 2018 (pending). Licensing Contact: To license this technology, please contact Elizabeth Pitts, Ph.D., 240–669–5299; elizabeth.pitts@nih.gov. Dated: March 18, 2021. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2021–06476 Filed 3–29–21; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: The Development of Natural Killer (NK) Cell Kita-Kyushu Lung Cancer Antigen 1 (KK–LC–1) T Cell Receptor (TCR) Therapy for the Treatment of KK–LC–1 Expressing Human Cancers AGENCY: National Institutes of Health, HHS. ACTION: Competitive Advantages 16603 Notice. The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice Zelluna Immunotherapy (Zelluna), located in Oslo, Norway. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before April 14, 2021 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Abritee Dhal, Ph.D., Technology Transfer Manager, at Telephone: (240) 276–6154 or at Email: abritee.dhal@nih.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Intellectual Property U.S. Provisional Patent Application 62/327,529 entitled ‘‘Anti-KK–LC–1 T Cell Receptors’’ [HHS Ref. E–153–2016– 0–US–01], PCT Patent Application PCT/ US2017/027865 entitled ‘‘Anti-KK–LC– 1 T Cell Receptors’’ [HHS Ref. E–153– 2016–0–PCT–02], Australian Patent Application 2017258745 entitled ‘‘AntiKK–LC–1 T Cell Receptors’’ [HHS Ref. E–153–2016–0–AU–03], Canadian Patent Application 3021898 entitled ‘‘Anti-KK–LC–1 T Cell Receptors’’ [HHS Ref. E–153–2016–0–CA–04], European Patent Application 1733120.4 entitled ‘‘Anti-KK–LC–1 T Cell Receptors’’ [HHS Ref. E–153–2016–0–EP–05], United States Patent Application 16/096,118, entitled ‘‘Anti-KK–LC–1 T Cell Receptors’’ [HHS Ref. E–153–2016–0– US–06], and U.S. and foreign patent applications claiming priority to the aforementioned applications. The patent rights in these inventions have been assigned and/or exclusively E:\FR\FM\30MRN1.SGM 30MRN1

Agencies

[Federal Register Volume 86, Number 59 (Tuesday, March 30, 2021)]
[Notices]
[Pages 16602-16603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for

[[Page 16603]]

licensing to achieve expeditious commercialization of results of 
federally-funded research and development. Foreign patent applications 
are filed on selected inventions to extend market coverage for 
companies and may also be available for licensing.

FOR FURTHER INFORMATION CONTACT: Elizabeth Pitts, Ph.D., 240-669-5299; 
[email protected]. Licensing information and copies of the patent 
applications listed below may be obtained by communicating with the 
indicated licensing contact at the Technology Transfer and Intellectual 
Property Office, National Institute of Allergy and Infectious Diseases, 
5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows.

Protein Nanoparticle-Based Vaccine for Influenza Virus

Description of Technology

    There is a great need for a broadly protective, ``universal'' 
influenza virus vaccine. Most influenza vaccines target the head of the 
influenza surface glycoprotein hemagglutinin (HA). However, this region 
of the HA protein undergoes fast antigenic drift. The current strategy 
to address this issue is to reformulate influenza vaccines annually 
against dominant circulating strains, but this leads to variable 
protective efficacy against annual epidemic strains and will not 
provide protection against novel influenza viruses with pandemic 
potential. A ``universal'' influenza vaccine could improve seasonal 
vaccination and provide pandemic preparedness.
    Broadly neutralizing antibodies with heterosubtypic binding have 
been discovered. However, commercial development of vaccines that 
produce broadly neutralizing antibodies has so far been unsuccessful. 
Researchers at NIAID used structure-guided techniques to identify and 
develop nanoparticles that express a conserved peptide from the HA 
stem, a preferred antigen for influenza vaccine development as it 
evolves slower than the HA head. The nanoparticles of this invention 
elicit antibodies to the HA stem, confer protection in mouse challenge 
models, are cross-reactive to heterosubtypic HA subtypes, and are heat 
stable. Additionally, the protein platform of the nanoparticles can be 
expressed for group 1 and group 2 influenza HA (H1 to H16), which 
allows mixing of antigens. This vaccine technology has great potential 
to provide protection against both annual influenza outbreaks and 
pandemic-potential influenza viruses.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404.

Potential Commercial Applications

     Vaccines against influenza virus.
     Universal influenza virus vaccine.

Competitive Advantages

     Broad/universal protection against both seasonal and 
pandemic-potential influenza viruses.
     Nanoparticles allow mixing of antigens.
     Incorporates epitopes from group 1 and groups 2 influenza 
viruses.
     Stability of particle and immunogenicity after high 
temperature exposure.

Development Stage

     In vivo data assessment (animal).
    Inventors: Audray K. Harris (NIAID) and Dustin McCraw (NIAID).
    Intellectual Property: HHS Reference No. E-005-2017--U.S. 
Provisional Application No. 62/540,474, filed August 2, 2017; PCT 
Application No. PCT/US2018/045032, filed August 2, 2018; United States 
Application No. 16/635,240, filed January 30, 2020 (pending); European 
Application No. 18756111.3, filed August 2, 2018 (pending); Chinese 
Application No. 201880063622.5, filed August 2, 2018 (pending); and 
Indian Application No. 202017008138, August 2, 2018 (pending).
    Licensing Contact: To license this technology, please contact 
Elizabeth Pitts, Ph.D., 240-669-5299; [email protected].

    Dated: March 18, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-06476 Filed 3-29-21; 8:45 am]
BILLING CODE 4140-01-P
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